NMPA (CFDA) Updates
January 18, 2021
NMPA granted Innovative Device Approval to the CT Imaging Assisted Pulmonary Nodule Detection Software produced by Hangzhou Deepwise on December 1, 2020. This is the second AI innovative product approved by […]
January 18, 2021
NMPA published twelve guidelines on December 9, 2020. Among all the guidelines, seven of them are for IVD products and five are for nomenclature. The guidelines are put in place […]
January 18, 2021
NMPA released the updated Medical Device Classification Catalog on December 31, 2020, providing modification on management category and device classification. Complete List 15 medical devices are down-classified, including seven class […]
January 18, 2021
NMPA announced its preparation of “Technical Review Guideline of Diagnostic Software for Diabetic Retinopathy (DR)” and “Technical Review Guideline of Image Ultrasonic Diagnostic Based AI Software” for public comments on December […]
January 15, 2021
China UDI system for the first group of devices will take effect on January 1, 2021. For the medical devices listed in the “First Group of Unique Device Identification Devices”, […]
January 15, 2021
Fourteen medical devices and three drugs are piloting in the Real-World Data (RWD) Program in Hainan, according to RWD Initiation Meeting in Beijing on December 28, 2020. It is the […]
January 10, 2021
Historical changes of medical device industry has been made in China. Amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council […]
December 23, 2020
A “Beijing Medical Ethics Committee (EC) Review Mutual Recognition Alliance” was formed on December 1, 2020. The mutual recognition alliance currently consists of fifteen member institutes. It will greatly accelerate […]
December 23, 2020
Unapproved medical devices can be clinically used in China’s Big Bay Area of Guangdong, Hong Kong, and Macao with over 70 million people. As long as they are used in […]
December 9, 2020
The NMPA granted Innovation Approval for a Peripheral Drug-Eluting PTA Balloon Catheter produced by Zylox Medical on November 11, 2020. For the NMPA Innovation Device Review Report on the Peripheral Drug-Eluting […]
December 9, 2020
“The designated medical institutions in the region can use medical devices that are urgently needed for clinical use, and have been purchased and used by public hospitals in Hong Kong […]
December 4, 2020
NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostic (IVD) (draft)” for comments on November 25, 2020. Feedback needs to be submitted by December 15, 2020. Differences between […]